Identification of Molecular Biomarkers for Cancer Target Therapy Efficacy

NCT03724097 | Unknown FDA Drug

• 1 other identifier: OB0052018
• Study Type: observational
• Target: 200
• Locations: 2 countries
• Sites: 7

Brief Summary

This is a prospective trial for a computation-based efficacy prediction method for anticancer target therapies. The original computational algorithm utilizes individual transcriptome data of a cancer sample and assesses changes at the level of gene expression and intracellular signaling pathways. By applying the database of known molecular targets of anticancer target drugs it allows to rank potential efficacies of target drugs.

Conditions

Cancer

Keywords

biomarkers; target therapy; NGS; RNAseq; mRNA; transcriptome analysis; signaling pathway; intracellular molecular pathway; Oncobox; Next generation sequencing; RNA sequencing

Outcome Measures

Primary Outcomes (3)

• Tumor response

  Tumor response according to the results of instrumental studies

  2 years

• Time to progression

  Time to progression

  2 years

• Time to progression compared to the previous therapy lane

  Time to progression compared to the previous therapy lane

  2 years

Secondary Outcomes (1)

• Overall survival

  2 years

Study Arms (3)

Group 1

Patients receiving target drugs with the score value above 0,1 as monotherapy or in combination

Other: RNA sequencing; Other: Transcriptome analysis; Drug: target drug with the score above 0,1

Group 2

Patients receiving only non-target drugs or target drugs with the score value equal to or below 0,1 as monotherapy or in combination

Other: RNA sequencing; Other: Transcriptome analysis; Drug: target drug with the score equal or below 0,1; Drug: non-target drug

Group 3

Patients receiving palliative care

Other: RNA sequencing; Other: Transcriptome analysis; Drug: palliative care

Interventions

RNA sequencing OTHER

Next Generation Sequencing of RNA from tumor samples, rRNA-depleted.

Also known as: RNA-seq

Group 1; Group 2; Group 3

Transcriptome analysis OTHER

Analysis of RNA-seq data using the Oncobox algorithm.

Group 1; Group 2; Group 3

target drug with the score above 0,1 DRUG

target drug with the score above 0,1

Group 1

target drug with the score equal or below 0,1 DRUG

target drug with the score equal or below 0,1

Group 2

non-target drug DRUG

non-target drug

Group 2

palliative care DRUG

palliative care

Group 3

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Oncological patients

You may qualify if:

• Adults, diagnosed with cancer;
• Age 18 - 80;
• Patients who previously received anticancer treatment within the standard care, patients for whom standard therapy was not indicated or patients refused to receive standard therapy. Patients could receive an unlimited number of treatment lines before this study;
• Available formalin fixed, paraffin-embedded (FFPE) samples of cancer tissue. The material should be confirmed by a certified pathologist, the sample taken for the analysis should contain at least 70% of tumor cells;
• Patients who have signed an informed consent.

You may not qualify if:

• Lack of tumor biopsy material, inability to obtain a new tumor biopsy.

Sponsors & Collaborators

• OmicsWay Corp.: lead
• Oncobox Ltd: collaborator
• Vitamed LLC: collaborator
• N.N. Blokhin National Medical Research Center of Oncology: collaborator
• Kaluga Regional Clinical Oncology Center: collaborator
• Multidisciplinary medical holding SM-Clinic: collaborator
• Oncological Clinical Dispensary No. 1 of the Moscow City Health Department: collaborator

Study Sites (7)

OmicsWay Corp.

Walnut, California, 91789, United States

Location

Kaluga Regional Clinical Oncology Center

Kaluga, 248007, Russia

Location

Oncological Clinical Dispensary No. 1 of the Moscow City Health Department

Moscow, 105005, Russia

Location

Multidisciplinary medical holding "SM-Clinic"

Moscow, 109316, Russia

Location

N.N. Blokhin National Medical Research Center of Oncology

Moscow, 115478, Russia

Location

"Oncobox" Ltd.

Moscow, 121205, Russia

Location

Vitamed LLC

Moscow, 121309, Russia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Formalin-fixed, paraffin-embedded pathological cancer samples obtained during surgery or core needle biopsy

MeSH Terms

Conditions

Neoplasms

Interventions

Sequence Analysis, RNA; RNA-Seq; Gene Expression Profiling; Drug Delivery Systems; Palliative Care

Intervention Hierarchy (Ancestors)

Sequence Analysis; Genetic Techniques; Investigative Techniques; High-Throughput Nucleotide Sequencing; Drug Therapy; Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Anton A Buzdin, Ph.D., D.Sc

  OmicsWay Corp.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2018
• First Posted: October 30, 2018
• Study Start: October 17, 2017
• Primary Completion: April 1, 2021
• Study Completion: November 1, 2022
• Last Updated: September 14, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Beginning 3 months after trial completion, no end date
• Access Criteria: Anyone

Locations

RU (6); US (1)